SciBase Holding AB (publ) ("SciBase" or the "Company") today announces the outcome of the exercise of warrants of series TO1 which were issued in connection with the Company's 19,941,721 units issue on 26 March 2020. The outcome shows that a total of 18,220,264 warrants were exercised for subscription of 18,220,264 new shares in the Company, corresponding to 91.4 percent of the total number of warrants issued in series TO1.

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.
 

The board of directors of SciBase resolved, on 26 March 2020, to carry out a fully guaranteed rights issue of up to 19,941,721 units at a subscription price of SEK 1.25 per unit. Each unit consisted of one (1) share and one (1) warrant free of charge, and every warrant entitled the holder to subscribe for one (1) new share in the Company.

In total, 18,220,264 warrants of series TO1 have been used for subscription of 18,220,264 shares, meaning that approximately 91.4 percent of the total number of warrants issued in series TO1 were used for subscription of shares. SciBase is hereby provided with a total of approximately SEK 31.9 million before deduction of issue costs.

Through the exercise of 18,220,264 warrants of series TO1, the number of shares and votes in the Company will increase by 18,220,264, from 36,559,822 to 54,780,086 shares and votes. The share capital hereby increases with SEK 911,013.20, from SEK 1,827,991.10 to SEK 2,739,004.30. The dilution for shareholders' who did not exercise any warrants for subscription of new shares amounts to a total of approximately 33.3 percent based on the total number of shares in the Company following the completion of the rights issue and the exercise of the warrants.

The new shares subscribed for by exercise of warrants series TO1 are expected to be admitted for trading on First North Growth Market around October 29, 2020.

Full terms and conditions regarding the warrants and information about the Company is available in the prospectus which was approved by the Swedish Financial Supervisory Authority (the "SFSA") and published by the Company on 8 May 2020. The prospectus is available on the Company's website http://investors.scibase.se/sv as well as the SFSA's website www.fi.se.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: [email protected]

Certified Advisor (CA):

Avanza

Tel: +46 8 409 421 20

Email: [email protected]

About SciBase and Nevisense

SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

Important information

Publication, distribution or release of this release can in some jurisdictions be subject to restrictions by law and persons in those jurisdictions where this release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this release is responsible to use this release and information herein in accordance with applicable rules in respective jurisdiction. This release does not contain or constitute an offer, nor an invitation, to acquire or subscribe for shares or other securities in the Company in any jurisdiction, either from the Company or from any others.

The information in this release may not be distributed or sent into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa the United States or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. Acts in contrary to this instruction can constitute a crime according to applicable securities laws. This release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exemption from registration, according to the applicable U.S. Securities Act from 1933 ("Securities Act"), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States.

This release is not a prospectus in accordance with the definition in the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). Complete information regarding the rights issue and the warrants can only be obtained through the prospectus approved by the Swedish Financial Supervisory Authority on 8 May 2020 which is available on the Company's website.

This information is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). This information must not be acted on or relied upon by persons who are not Relevant Persons. An investment or an investment activity referred to in this release is only available in the United Kingdom for Relevant Persons and will only be conducted with Relevant Persons.

This release may include forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and beyond the Company's control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

Information to distributors

For the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) national implementing measures, (together the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the offered shares have been subject to a product approval process, who have established that these shares are: (i) suitable for a target marked consisting of non-professional investors and investors who fulfil the criteria for professional clients and eligible counterparties, each as defined in MiFID II, and (ii) suitable for distribution through all distribution channels that has been approved in MiFID II ("Target Market Assessment"). Irrespective of the Target Market Assessment, distributors should note that: the price of the shares in the Company may decline and investors could lose all or part of their investment; the Company's shares offer no guaranteed income and no capital protection; and an investment in the Company's shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The target market assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the issues.

The target market assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, purchase, or take any other action whatsoever with respect to the Company's shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Company's shares and determining appropriate distribution channels.

STOCKHOLM, SWEDEN, - October 30, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the release of the first device based on their new platform, Nevisense Go.

Nevisense Go is a handheld and fully portable device the size of a large Pen. It combines the company's core Electrical Impedance Spectroscopy (EIS) measurement technology with a new AI-based analysis platform embedded in the device. The result is a flexible platform that will be significantly easier to both collect data and develop applications on. It will also mean products that are easier for clinicians to use and to integrate into a clinic, and better acceptance by patients.

As previously communicated, the first Nevisense Go version is released for skin barrier assessment and is targeted at researchers and Industry Partners. One of the first sales of the product is to one of the largest global industrial players, and it is this type of customer that we are initially focused on. The first release is for research and does not include a clinical indication (i.e. is released as a non-medical device), but there is significant potential within the research market, and we believe it will lead to many new applications for the technology.  From this base, SciBase will continue to develop the platform, add indications and work through the regulatory processes to deliver the next generation of new products.

 `Nevisense Go represents an important milestone for SciBase. We have spent several years gaining acceptance for our methodology and we have developed a platform that builds on what we have learned but adds many advantages for our customers and broadens considerably the potential size of our market' says Simon Grant, CEO of SciBase `Today's release is the first step with our new platform and as we deliver clinical indications from next year, we expect this to drive revenue, especially when it comes to electrode sales. In the medium term we hope to expand the use of Nevisense Go into broad new areas and to broader customer groups - expending from specialists to GPs and even potentially to use in the home.'

SciBase's product Nevisense for melanoma detection was one of the first AI-based products approved within medicine. Nevisense Go is the next generation of that product platform and builds on the experience that SciBase has gained in over 100,000 clinical patient tests. Nevisense Go is the culmination of 5 years of work and 20+ years of diagnostic experience. Together with the KTH Royal Institute of Technology, SciBase has miniaturized their EIS measurement technology onto a single `chip' or application specific integrated circuit (ASIC). Together with our AI partner Peltarion SciBase has developed an agile environment for AI algorithm development and together with the Swiss Institute of Allergy and Asthma Research (SIAF), our research partner in Davos, SciBase has developed the world's first AI-algorithms for assessment of the skin barrier. Studies in SIAF demonstrated the correlation of EIS measurements with skin barrier defects caused by enzymes, toxins and environmental agents such as detergents in mouse models and in skin barrier defective patients.   

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected] 

About SciBase and Nevisense
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

Stockholm, Sweden and New York, USA - August 26, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that they will participate in a clinical study to run parallel to the ACTIVATE study (sponsored by the Immune Tolerance Network and the NIAID/NIH), which is being conducted by the Department of Pediatric Allergy at Mount Sinai Hospital in New York.

The goal of the ACTIVATE study is to explore how differences in the gut microbiome of an infant affect its susceptibility to allergies. The study will compare groups born vaginally with those born by Cesarean section with and without so-called "vaginal seeding" of the infant microbiome. The study will examine whether vaginal seeding lowers the risk that infants test positive for allergies at one year of age. ACTIVATE will enroll 120 pregnant women and their babies, and will focus on those babies that are at higher-risk for developing allergies.

The infants will be followed for the first year of life, and SciBase's product Nevisense will be used to measure skin properties including barrier function and evaluate whether these measurements can help predict the development of allergies or monitor their progress.

"We look forward to adding Nevisense to the study and together with SciBase identify opportunities where these measurements can help clinicians manage these patients" says Dr. Hugh Sampson, Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and Director Emeritus of the Jaffe Food Allergy Institute.

"We are excited to participate in this clinical study which may help provide important guidance on how to reduce the risk that an infant will develop allergies. We look forward to seeing how our unique measurement methodology can help clinicians gain new insight into the skin of these infants and in doing so hopefully help this patient group" says Simon Grant, CEO of SciBase.

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected] 

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

STOCKHOLM, SWEDEN, - September 16, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that both the Journal of the American Academy of Dermatology (JAAD) and SKIN, The Journal of Cutaneous Medicine (SKIN), have published studies assessing the clinical impact of Nevisense. The studies compared the results of US clinicians evaluating atypical pigmented skin lesions (atypical moles) using visual evaluation only compared to visual evaluation and the Nevisense result combined.

The JAAD publication titled "Impact of Electrical Impedance Spectroscopy on Dermatologists' Number-Needed-to-Biopsy Metric and Biopsy Decisions for Pigmented Skin Lesions"  sought to evaluate improvements in clinical accuracy in melanoma detection, while the SKIN publication titled "Integrating Electrical Impedance Spectroscopy into Clinical Decisions for Pigmented Skin Lesions Improves Diagnostic Accuracy: A Multitiered Study" sought to evaluate the differences between practicing dermatologists, physician's assistants, nurses and residents. All clinician types (dermatologists, physician's assistants, nurses and residents) improved by similar amounts, and the clinicians with the lowest number of correct evaluations improved the most. The publications are based on clinical evaluations of lesions in reader studies. The JAAD publication included 267 dermatologists while the SKIN publication included 591 clinicians (dermatologists, physician's assistants, nurses and residents). All clinicians evaluated lesions using visual evaluation only, and then they added the Nevisense information in over 25,000 evaluations.The key study takeaways were:

• The number of `missed melanomas' fell from ~7% to < 1%
• Overall sensitivity (ability to correctly identify melanoma) increased on average across the groups by 14% and specificity (ability to accurately identify benign moles) by 10.2%
• In total, clinicians identified 1,343 more melanomas with Nevisense compared to visual evaluation alone. 
• All clinician types (dermatologists, nurses and residents) improved a similar amount, and the clinicians with the lowest number of correct evaluations improved the most.
• In the JAAD study, dermatologists improved their sensitivity from 84 to 98%, their specificity from 34% to 44% and their NNB (Number Needed to Biopsy) from 6.3 to 5.3.

"Melanoma is the deadliest form of skin cancer, but when detected early, treatment has a nearly 100% cure rate making early detection critical to survival. These studies show a significant reduction of missed melanomas from ~7% to less than 1%, a further indication of the clinical value Nevisense can bring by helping clinicians identify melanomas and improve performance across the board. This is the first time this type of study has been performed and we are pleased with the results," stated Dr. Darrell S. Rigel, Clinical Professor, Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. "These results further demonstrate the benefits of early melanoma detection with Nevisense, and I am pleased that we are able to share our findings with the clinical community demonstrating the benefits of this technology for patients."

"Clinicians face difficult decisions every day when they evaluate moles, so it was very positive to see that Nevisense could so significantly improve their accuracy. Nevisense was able to help clinicians of all levels of experience, and especially those who were most in need of support," said Simon Grant, CEO of SciBase.  "Dr. Rigel's studies confirmed what we see from our users in the field - significant clinical benefit for both clinicians and patients. This is further proof of the potential for Nevisense to improve the standard of care of melanoma detection in the United States and will provide timely support to our ongoing reimbursement process."

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor (CA):
Avanza
Tel: +46 8 409 421 20
Email: [email protected] 

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

I trust that you have all had a safe and enjoyable summer. Given the high level of interest we have seen from you, our shareholders, I felt it time I update you on where we are as a Company and our plans for the near future.We are making considerable progress in transforming SciBase from a single application Company built around melanoma detection to a platform Company with applications in several different clinical areas. We believe this will build significant shareholder value. With our unique platform and AI-based applications we are expanding our product line to address new markets with a large potential. Though there are many challenges in the current Covid-19 environment, I am very proud of the progress the team is making on this journey.

The summer has been extremely busy for SciBase. We have seen a return of the market for Nevisense tests in both Germany and the US after the negative effects we saw due to Covid-19 earlier this year. In addition to this return of base business, we have made real progress with our growth projects - our new clinical applications and our new platform, Nevisense Go. All this has been under the backdrop of a massive effort to secure certification under the new European medical device regulations, `MDR' (Medical Device Regulation).

I will take you through each of these points, starting with Nevisense Go, as this is by far the topic we receive the most questions about from shareholders.

Nevisense Go - Release and next steps

I am very pleased to announce that we expect to release the first version of the Nevisense Go platform on October 29th 2020. It has taken us a little longer than expected because of the pandemic and the very resource intensive MDR process, which we will discuss below. As previously communicated, this first version will be for the assessment of the skin barrier using inbuilt AI software. It will be fully functional as an impedance measurement device like Nevisense and utilize the same electrode and business model. It will however be simpler, easier to use and significantly less expensive.

This release of Nevisense Go is aimed at Industry partners and researchers within the area of skin barrier, though our aim is for Nevisense Go to eventually support all our clinical applications. Our activities so far lead us to believe that the market potential for research and Industry partners is significant and is a good first step for the product. The product can be used to investigate the skin barrier but is not as of yet linked to any clinical indications (such as eczema or melanoma).

Nevisense Go is the culmination of more than four years of work together with KTH Royal Institute of Technology and our clinical partners SIAF in Davos, but on the other hand is just the very first step for the platform. Our focus is now to continue to develop the platform and to collect clinical data so that we can perform the regulatory work needed to release indications starting next year.

COVID-19 and the Market

The pandemic had a significant effect on our customers in Germany and New York during the second quarter, and also slowed our rollout with Advanced Dermatology and Cosmetic Surgery (ADCS) somewhat. We saw however, increased interest in our products from the beginning of June and the return of orders from existing customers. This is very positive, though in general for the industry, customers have remained hesitant to invest in new devices. Overall, the third quarter appears back on track, and this is driving our hope that we will achieve one of our goals for 2020 - profitability in the Germany market on a local basis.

The bottom line is that after a very tough period the market, customers and patients are returning.

New applications and MDR

SciBase is entering a phase where we move from a single indication (melanoma) to multiple indications by adding non-melanoma skin cancer (NMSC) and skin barrier assessment. All indications are based on the same base Electrical Impedance Spectroscopy (EIS) + AI technology, the same electrode technology, and the same business model.

The release of new applications covering these indications is closely intertwined with the introduction of the new EU medical industry regulations, MDR. A company wanting to sell in Europe must have MDR in place if they wish to approve new indications, even if MDR only becomes mandatory from May 2021.

Our NMSC application is an add-on software module for Nevisense and as such will be targeted at the same customer group as melanoma. The product is complete and is awaiting approval under MDR. The initial clinical data evaluation has been positive. When released, we expect many customers to add this functionality and hope that the combination also helps us attract new customers. Though NMSC usually has a lower risk profile than melanoma, there are many more patients with NMSC than with suspected melanoma - in Sweden for example the ratio is at least 10 to 1.

Skin Barrier assessment is actually a group of applications that are linked to diseases connected to the skin barrier. We see uses for our technology in the prediction, improved diagnosis, and management of atopic diseases such as atopic dermatitis (eczema) and food allergies. These are very common diseases, and we see a large potential. The first step as discussed above is the release of Nevisense Go for barrier measurement and we are targeting Industry partners and researchers where we are collecting data to support new barrier applications.

US progress

It was very pleasing to see the publication of two new studies in JAAD and SKIN last week from Professor Darrel Rigel's team in New York. The reader studies evaluated the impact of Nevisense information on clinicians' decision-making. Nearly 600 US clinicians performed over 25,000 evaluations comparing management decisions first using visual evaluation only, and then with the addition of Nevisense information. The results were impressive - an average improvement in sensitivity of 14% (ability to detect melanoma) and an average improvement in specificity (ability to correctly classify as benign) of over 10%.

We have installed 6 systems in clinics in Florida and Michigan with our partner Advanced Dermatology and Cosmetic Surgery. We have several further installations planned and our hope is that we can move this first phase forward over the coming weeks.

We see the current period as the beginning of the next phase in the development of SciBase as a company. We will continue to build on our melanoma business not only in Germany, but also in the US. We will start the transition from Nevisense to Nevisense Go and in doing so broaden our customer focus. And finally, we will start the transformation from a `single product company' to a company with multiple legs to stand on with the addition of NMSC and Barrier. We are making considerable progress and have laid the foundation for accelerated future growth.

Best Regards

Simon Grant, CEO

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected]

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com

Anna Danström, SciBase's head of production and supply chain, has chosen to leave her position and accept a role at another company. Linn Olsen will replace Anna as production and supply chain manager. Linn has a broad background within production, QA and Medtech, and comes from Trimble.

 "I would like to take the opportunity to thank Anna for her exceptional work at SciBase, and especially at our Uppsala facility. Anna has ensured that we have a well-functioning electrode manufacturing process and team and has also played a key role in improving our electrode gross margin. I wish Anna all the best in her future role, and welcome Linn to the team", says Simon Grant CEO SciBase.

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected]

The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

As many of us head into a holiday break, I thought I would send out a short update, especially aimed at keeping our newer shareholders in the loop. On the whole things are progressing well, though we have several challenges due to the pandemic.

US activity

Nevisense 3.0 has been very well received by our US customers. We continue with two main focus areas in the US: our partnership with practice groups like Advanced Dermatology and Cosmetic Surgery (ADCS) and the reimbursement process. While the situation in New York is improving all the time, the high number of COVID-19 cases in Florida is a cause for some concern as we are establishing our first pilot cluster with ADCS in central Florida. Things are going well so far, and we expect to have four sites around Orlando up and running by the end of this week, which is great to see and a good indication that we are delivering value. Working with dermatology practice groups such as ADCS is a key part of our US strategy as this allows us to reach many sites through a single channel. The reimbursement application process is progressing, and we hope to receive feedback on our application in the coming months.

We saw some good development in Q1, with repeat orders of electrodes from our New York based dermatology practice group, Advanced Dermatology, P.C. (similar name but no connection to ADCS), and we just now see the return of such orders.  COVID-19 hit all New York clinics hard, but interest is clearly coming back.

New Indications, Products and MDR

Our focus internally at SciBase in Stockholm is on our new products and indications, and as part of these activities the company is working to finalize Medical Device Regulation (MDR) certification.  This is mandatory from May of 2021 after being delayed a year due to the pandemic and for approval of new indications such as Non-Melanoma Skin Cancer (NMSC), MDR is a necessity. Overall things are progressing well. The product is complete and the clinical data was submitted in April, but the regulatory process has been affected by Covid. We see some delays during the second half of the year, including a one-month delay in our MDR audit due to travel restrictions.  This is a somewhat fluid situation, and we will do our best to keep you informed.

Nevisense Go is our next generation platform, a hand-held version of Nevisense that uses the same electrodes and business model as the regular Nevisense. Our strategy with Nevisense Go is to start with the Barrier application and over time also add support for further and more specific applications, utilizing different AI models. Our first priority is Industry partners, and we see the potential to utilise Nevisense Go outside the specialist clinic and eventually in retail or even in the home. The first release of Nevisense Go is delayed somewhat into Q3 due to delays with MDR and at our contract manufacturer, but we are making significant progress.

Progress with Barrier

When it comes to the skin barrier application overall, things are also progressing. The method and some our clinical results were presented by Prof Cezmi Akdis in his presentation `Epithelial cell barrier and allergic diseases' at the recent digital EAACI meeting. Our methodology was also discussed by Kazunari Sugita in a review paper titled `Outside-in hypothesis revisited' published in May in the Annals of Allergy, Asthma and Immunology. The article abstract is available at https://doi.org/10.1016/j.anai.2020.05.016.

We continue to see good levels of industry interest in the combination of Nevisense Go and the barrier application. The ability to embed a neural network model into the stand-alone Nevisense Go is a unique accomplishment and I will be presenting this and other progress at the upcoming Redeye Artificial Intelligence Seminar 2020 on September 17th - see https://www.redeye.se/events/788494/artificial-intelligence-seminar-2020 for more details.

COVID-19 and the Market

The pandemic had a significant effect on our customers in Germany and New York during the second quarter. We have seen increased interest in our products in June and the beginning of July, but it is difficult to estimate how Q3 will be affected. The bottom line is that after a very tough period the market, customers and patients are coming back.

Increased interest and new Share Issue, and next steps

We were happy with the result of the share issue. The issue was considerably oversubscribed. We also saw an increased interest in the Company and our share during the second quarter with increased volumes traded resulting in us welcoming an additional ~ 1,000 shareholders and we want to thank them for their confidence in SciBase. As a result of the issue and the increased volumes traded there have been a couple of changes in our ownership. Petter Stordalen (Strawberry) has sold their shares in SciBase and we believe this is because of the pressure COVID-19 has put on their core business.

Phase 2 of our share issue involves the conversion of warrants. These warrants are currently traded using the ticker SCIB TO 1 and warrant-owners will be given the option to convert warrants to shares between October 5 - October 16 2020 at a value based on the average share price over the ten days preceding September 30th. The subscription price for a share will be from a minimum of SEK 1.00 to a maximum of SEK1.75.

We have been very busy, and we expect our high level of activity to continue through the rest of the year. Overall it feels like we are making considerable progress. The pandemic's effects remain a factor in our plans - and though we do our best to mitigate those effects, they may affect the timing of some of our activities. Internally our focus is very much on the new products and externally we are heartened by a return of our core Private Dermatologist market.

Best Regards and enjoy your holiday

Simon Grant, CEO

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected]

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com

Stockholm, Sweden and New York, USA - August 18, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that Nevisense will be included in a large clinical study initiated by The Ronald O. Perelman Department of Dermatology clinic at NYU Langone Health.  

The SpotCheck study will investigate the use of Nevisense as a point-of-care diagnostic tool to assist with skin cancer detection in a remote setting such as a non-specialist practice or pharmacy. The study will evaluate how Nevisense can help providers assess patients' irregular moles in such locations, and if successful will help improve access for patients to technology for the early detection of melanoma.

David Polsky, MD, PhD., the Alfred W. Kopf, M.D. Professor of Dermatologic Oncology at NYU Langone Health and Perlmutter Cancer Center will serve as the Primary Investigator for the study. "We are very interested in developing new methods to extend expert skin cancer diagnostic services to communities lacking access to in-person specialist care. We believe that Nevisense can help improve the accuracy of visual diagnosis in a telemedicine-based system", says Dr. Polsky who is also Director of its Pigmented Lesion Section in the Ronald O. Perelman Department of Dermatology and a professor in the  Department of Pathology at NYU Langone.

Simon Grant, CEO of SciBase, stated, "We are delighted that NYU has selected Nevisense for this very important study. There is clearly a need for improved tools for non-specialists to assess atypical pigmented lesions. The objective data Nevisense provides may effectively help in remote settings such as pharmacies, and not only provide much needed support for clinicians and patients but open up a significant new opportunity for SciBase."

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]  

For more information, please contact:
Avanza
Tel: +46 8 409 421 20
Email: [email protected]  

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

January 1 - June 30, 2020

The second quarter in figures

• Net sales amounted to TSEK 1,683 (2,168).
• The loss after tax amounted to TSEK 8,864 (10,613).
• The loss per share amounted to SEK 0.38 (0.64).
• The cash flow from current operations was negative in the amount of TSEK 8,704 (9,900).
• The gross margin reached 55.7% (53.3%).
• Electrode sales volume decreased by 18% and reached 4,672 (5,712) units. Repeat sales of electrodes to existing customers decreased by 22%.

The first half-year in figures

• Net sales amounted to TSEK 4,179 (4,536).
• The loss after tax amounted to TSEK 17,800 (19,520).
• The loss per share amounted to SEK 0.89 (1.17).
• The cash flow from current operations was negative in the amount of TSEK 16,597 (18,850).
• The gross margin reached 54.7% (52.9%).
• Electrode sales volume decreased by 4% and reached 11,270 (11,792) units. Repeat sales of electrodes to existing customers decreased by 8%.

Important events during the quarter

• The Covid-19 pandemic started to affect SciBase from mid-March and continued through the second quarter. Sales in the company's key market Germany were affected and decreased by 25% in the quarter, and overall sales decreased by 23%. Customer interest and sales seems to be returning to normal from the end of Q2.
• SciBase received FDA approval for Nevisense 3.0.
• SciBase entered into a partnership agreement with the Advanced Dermatology and Cosmetic Surgery group (ADCS), the single largest dermatology network in the US with over 150 practices. The first systems were installed in Florida in June.
• SciBase rights offer was heavily oversubscribed raising net MSEK 19.3 (after issue costs).
• SciBase submitted a reimbursement code application in the US.
• Anna Danström, SciBase's head of production and supply chain chose to leave her position and accept a role at another company.
• Extraordinary general shareholders' meeting was held on April 29th approving the Boards decision regarding the rights offering.
• The AGM was held on June 17th, 2020.
• The annual report for 2019 was published on April 5th.

Important events after the end of the     period

• Nevisense selected for `SpotCheck' remote melanoma detection evaluation study by The Ronald O. Perelman Department of Dermatology at NYU Langone Health in New York.

This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on August 20, 2020.

Contact person: Michael Colérus, CFO. +46 70 341 34 72

For more information, please contact: 
Simon Grant, CEO SciBase 
Phone: +46 72 887 43 99 
Email: [email protected]

Certified Advisor: 
Avanza AB 
Phone: +46 8 409 421 20 
Email: [email protected]

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.

Stockholm, June 15th, 2020 - SciBase, a global healthcare company with a platform technology enabling innovative products for skin disorders such as skin cancer and atopic dermatitis, today announces that the company has submitted a reimbursement code application for its melanoma application to the Centers for Medicare & Medicaid Services (CMS) in the US.

CMS oversees the administration of medical procedures within Medicare and Medicaid, and their codes are also utilized by third-party payers. Medicare covers healthcare for the elderly and Medicaid covers uninsured patients.

 "The SciBase team has delivered another important milestone and made significant progress in the US, positioning us for long-term sustainable growth. We are pleased that we have been able to submit our reimbursement code application to CMS without any delays given the challenges with the Covid-19 situation. The Medicare population is of particular interest to SciBase, given the higher rates of melanoma in the elderly. We continue to target 2021 for the first regional reimbursement coverage in the US.", says Simon Grant CEO SciBase.

SciBase has recently accelerated its activities delivering on significant milestones for its shareholders marking a step change in the speed in which the Nevisense 3.0 is capturing market acceptance and share in our focus markets, Germany and the US.

• Nevisense 3.0 was launched in Germany in late 2018 and delivered greatly improved clinical workflow, test throughput and customer satisfaction.

• In November of the same year, new clinical guidelines were published supporting the use of Nevisense in the evaluation of atypical lesions by Onkoderm (a German dermatology organization for skin cancer prevention and therapy). The launch of Nevisense 3.0, together with inclusion in German guidelines, contributed to sales growth of more than 30% in 2019 in Germany, driven by a 50% increase in the number patients tested.

• Following the launch of Nevisense 3.0 in Germany, the Company's sales increased six quarters in a row (compared with corresponding period the previous year).

• SciBase received FDA approval for Nevisense 3.0 in April 2020, and the Company now offers the third generation of Nevisense on the US market.

• In May 2020, a collaboration agreement between SciBase and the US largest dermatology chain, Advanced Dermatology and Cosmetic Surgery group (ADCS), was also initiated.

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
 

Certified Advisoer (CA):
Avanza
Tel: +46 8 409 421 20
Email: [email protected]

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.